Back to resultsSeroquel in Bipolar Depression Versus SSRI (EMBOLDEN II)
Primary Purpose
Bipolar Disorder, Bipolar Depression, Depression
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
quetiapine fumarate (Seroquel)
paroxetine
mood stabilizing activity
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, bipolar depression, depression
Eligibility Criteria
Inclusion Criteria: Male and female out-patients aged 18 to 65 years inclusive Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed Exclusion Criteria: Current period of depression lasting less than 4 weeks or more than 12 months Use of prohibited medication Substance or alcohol dependence or abuse Current suicide risk or suicide attempt within 6 months Breast feeding or pregnancy Clinically relevant disease or clinical finding
Sites / Locations
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Outcomes
Primary Outcome Measures
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measures
Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00119652
Brief Title
Seroquel in Bipolar Depression Versus SSRI
Acronym
EMBOLDEN II
Official Title
Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Bipolar Depression, Depression
Keywords
Bipolar disorder, bipolar depression, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
676 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate (Seroquel)
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Type
Behavioral
Intervention Name(s)
mood stabilizing activity
Primary Outcome Measure Information:
Title
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measure Information:
Title
Secondary variables supportive to the primary objective:
Title
MADRS total score response
Title
MADRS total score remission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female out-patients aged 18 to 65 years inclusive
Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Exclusion Criteria:
Current period of depression lasting less than 4 weeks or more than 12 months
Use of prohibited medication
Substance or alcohol dependence or abuse
Current suicide risk or suicide attempt within 6 months
Breast feeding or pregnancy
Clinically relevant disease or clinical finding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
National City
State/Province
California
Country
United States
Facility Name
Research Site
City
San Clemente
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Smyrna
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Northfield
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Everton Park
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Epping
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Providencia Santiago
Country
Chile
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
San Jose
Country
Costa Rica
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Thessaloniki
Country
Greece
Facility Name
Research Site
City
Tripoli
Country
Greece
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Yucatan
Country
Mexico
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
San Borja
Country
Peru
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Galati
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Magura
Country
Romania
Facility Name
Research Site
City
Benoni
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Gaziantep
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Manisa
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
20122366
Citation
McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26.
Results Reference
derived
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Seroquel in Bipolar Depression Versus SSRI
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